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Microalbumin testing kit (Immunoturbidimetry)
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Basic data
| Standard ID | YY/T 1969-2025 (YY/T1969-2025) |
| Description (Translated English) | Microalbumin testing kit (Immunoturbidimetry) |
| Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) |
| Classification of Chinese Standard | C44 |
| Classification of International Standard | 11.100.10 |
| Word Count Estimation | 9,959 |
| Date of Issue | 2025-06-18 |
| Date of Implementation | 2026-07-01 |
| Issuing agency(ies) | National Medical Products Administration |
| Summary | This standard specifies the requirements, marking, labeling, instructions for use, packaging, transportation, and storage of microalbumin assay kits (immunoturbidimetric assay), and describes the corresponding test methods. This document applies to kits for the quantitative detection of albumin in human urine samples using immunoturbidimetric assay. |
YY/T 1969-2025: Microalbumin testing kit (Immunoturbidimetry)
---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
CCSC44
Pharmaceutical Industry Standards of the People's Republic of China
Microalbumin Assay Kit (Immunoturbidimetric Method)
Published on 2025-06-18
Implemented on July 1, 2026
National Medical Products Administration issued
Foreword
This document complies with the provisions of GB/T 1.1-2020 "Standardization Work Guidelines Part 1.Structure and Drafting Rules of Standardization Documents".
Drafting.
Please note that some content in this document may involve patents. The issuing organization of this document assumes no responsibility for identifying patents.
This document was proposed by the National Medical Products Administration.
This document is under the jurisdiction of the National Technical Committee on Standardization of Medical Clinical Laboratory and In Vitro Diagnostic Systems (SAC/TC136).
This document was drafted by. Zhongyuan Huiji Biotechnology Co., Ltd., Chongqing Medical Device Quality Inspection Center, and Shanghai Clinical Laboratory Center.
Center, Beijing Institute for Medical Device Testing (Beijing Medical Biological Protective Equipment Testing and Research Center), Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Beijing Leadman Biochemical Co., Ltd., Beijing Jiuqiang Biotechnology Co., Ltd., Civil Aviation General Hospital, Beckman Coulter
Specialized Trading (China) Co., Ltd., and Siemens Medical Diagnostics Products (Shanghai) Co., Ltd.
The main drafters of this document are. Zhang Lihua, Ren Jiangtao, Ou Yuanzhu, Zhu Jinsheng, Wan Xianzi, Li Ran, Chen Yang, Wang Xuejing, Min Guihua, and Lai Liulian.
Microalbumin Assay Kit (Immunoturbidimetric Method)
1 Scope
This document specifies the requirements, labeling, instructions for use, packaging, and transportation of microalbumin assay kits (immunoturbidimetric assay).
Storage, and the corresponding experimental methods are described.
This document pertains to kits for the quantitative detection of albumin in human urine samples using immunoturbidimetry.
2 Normative references
The contents of the following documents, through normative references within the text, constitute essential provisions of this document. Dated citations are not included.
For references to documents, only the version corresponding to that date applies to this document; for undated references, the latest version (including all amendments) applies.
This document.
GB/T 191 Pictorial Symbols for Packaging and Storage
GB/T 21415 Metrological Traceability of Calibrators and Control Substances for the Measurement of Quantities in Biological Samples of In Vitro Diagnostic Medical Devices
Source
GB/T 29791.1 Information provided by manufacturers of in vitro diagnostic medical devices (labeling) Part 1.Terms, definitions and general terms
Require
GB/T 29791.2 Information provided by manufacturers of in vitro diagnostic medical devices (labeling) Part 2.Professional in vitro diagnostic reagents
3 Terms and Definitions
The terms and definitions defined in GB/T 29791.1 apply to this document.
4 Requirements
4.1 Appearance
Manufacturers should specify appropriate appearance requirements based on the product's packaging characteristics. Generally, this should include the composition and properties of each component of the reagent kit, as well as the inner and outer packaging.
Requirements include being intact and having clear labels.
4.2 Net content
The net content of liquid reagents should not be less than the labeled value.
4.3 Reagent blank absorbance
The absorbance of the reagent blank should meet the requirements claimed by the manufacturer.
Note. This applies only to immunoturbidimetry.
4.4 Analytical Sensitivity
When measuring a 30 mg/L sample, the absorbance difference should not be less than 0.02.
Note. This applies only to immunoturbidimetry.
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